On behalf of our multinational pharmaceutical partner who is dynamically growing, we are looking for a Regulatory Manager.
Overall responsibility for compiling regulatory submissions to European authorities PrepaReview regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, and compliance with regulatory standardsration and submission of product license applications, variations and renewals
Proactively monitor relevant governmental bodies to identify changes in legislation Provide regulatory expertise to other departments Regulatory project management Supervising packaging material related international operations Internal liaisoning with Production, QA and Logistics Correspondance with authorities and suppliers Reporting of performance indicators Implementing GMP and GDP requirements in the department Develop and maintain standard operating procedures and local working practices Training employees
University degree (preferably in Life Sciences) Experience in Regulatory in pharmaceutical industry(preferably at least 2 years) Fluency in English (written and oral, preferably at least at intermediate level) Fluency in German highly recommendated(written and oral) Working knowledge of Microsoft Office applications (Word and Excel) Flexibility and adaptability Accurate, organized and patient personality Ability to work well with others
Competitive salary Opportunity of continous advancement Energetic team
Elvárások / Requirements
Amit kínálunk / Offer
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